EMEA-001204-PIP02-14 - paediatric investigation plan

Ezetimibe

atorvastatin (calcium trihydrate)

Key facts

• Active Substance:
  • Ezetimibe
  • atorvastatin (calcium trihydrate)
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0079/2015
• PIP number:
  EMEA-001204-PIP02-14
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Prevention of coronary artery disease
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  10/04/2015

Decision

P/0079/2015: EMA decision of 10 April 2015 on the granting of a product-specific waiver for ezetimibe / atorvastatin (calcium trihydrate) (Atozet and associated names, Kexrolt and associated names, Orvatez and associated...

AdoptedReference Number: EMA/222887/2015